Patients and volunteers receiving single oral doses of 100 to 150 mg of almotriptan did not experience significant adverse events.Six additional normal volunteers received single oral doses of 200 mg without serious adverse events. During clinical trials with AXERT® (almotriptan malate) Tablets, one patient ingested 62.5 mg in a 5-hour period and another patient ingested 100 mg in a 38-hour period. Neither patient experienced adverse reactions.

Based on the pharmacology of 5-HT agonists, hypertension or other more serious cardiovascular symptoms could occur after overdosage. Gastrointestinal decontamination (i.e., gastric lavage followed by activated charcoal) should be considered in patients suspected of an overdose with AXERT®. Clinical and electrocardiographic monitoring should be continued for at least 20 hours, even if clinical symptoms are not observed.

It is unknown what effect hemodialysis or peritoneal dialysis has on plasma concentrations of almotriptan.

AXERT® (almotriptan malate) Tablets should not be given to patients with ischemic heart disease (angina pectoris, history of myocardial infarction, or documented silent ischemia), or to patients who have symptoms or findings consistent with ischemic heart disease, coronary artery vasospasm, including Prinzmetal's variant angina, or other significant underlying cardiovascular disease (see WARNINGS).

Because AXERT® may increase blood pressure, it should not be given to patients with uncontrolled hypertension (see WARNINGS).

AXERT® should not be administered within 24 hours of treatment with another 5-HT₁ agonist, or an ergotamine-containing or ergot-type medication like dihydro ergotamine or methysergide.

AXERT® should not be given to patients with hemiplegic or basilar migraine.

AXERT® is contraindicated in patients who are hypersensitive to almotriptan or any of its ingredients.

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